1. Field of the Invention
This invention relates to a new dot enzyme immunoassay (EIA) with a conserved portion of the envelope protein of the human immunodeficiency virus (HIV) as antigen. The immunoassay has been designed for use in areas with few laboratory facilities and by personnel with little laboratory experience. The test is simple to perform, economical, rapid (30 min), and stable.
2. Information Disclosure
Immunoassays for the detection of human antibodies against HIV are currently being used in laboratories to diagnose individuals infected with the AIDs virus. Carlson, J.R. et al. AIDS Serology Testing in Low- and High-Risk groups, JAMA, 253:3405-3408 (1985).
HIV antibodies have been found in saliva from infected individuals. The concentration of antibodies in saliva was 50 times less than in serum and a need for a reliable yet simple assay system for detection of HIV antibodies in saliva has been declared. Archibald, D.W., et al., "Salivary Antibodies as a Means of Detecting Human T Cell Lymphotropic Virus Type III/Lymphadenopathy-Associated Virus Infection,"J. of Clin. Microbiol., Vol. 24(5) 873-875 (1986).
The dot enzyme immunoassay is known. Lin T-M, and Halbert, S.P., Rapid Dot Enzyme Immunoassay for the Detection of Antibodies to Cytomegalovirus, J. of Clin. Microbiol. 24:7-11 (1986).
The preferred antigen for use in the disclosed immunoassay is described by Chang, T.W. et al., Detection of Antibodies to Human T-Cell Lymphotropic Virus-III (HTLV-III) with an Immunoassay Employing a Recombinant Escherichia Coli-derived Viral Antigenic Peptide, Bio/Technology 3:905-909 (1985).